US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class III · Low risk Terminated

Buprenorphine Transdermal System

Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

AVEVA Drug Delivery Systems, Inc. NDC 60505-7079-05 D-0466-2023
Class III · Low risk Terminated

Buprenorphine Transdermal System

Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

AVEVA Drug Delivery Systems, Inc. NDC 60505-7077-05 D-0465-2023
Class II · Moderate risk Terminated

Warfarin Sodium Tablets

Reason Failed Impurities/Degradation Specifications

Rising Pharmaceuticals NDC 57237-119-01 D-0348-2023
Class I · High risk Terminated

PrimeZEN Black 6000 capsule

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Volt Candy Wholesale Club D-0453-2023
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 36800-691-39 D-0912-2023
Class II · Moderate risk Terminated

Picnic

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company D-0911-2023
Class II · Moderate risk Terminated

allergy relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 11673-617-22 D-0910-2023
Class II · Moderate risk Terminated

allergyrelief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 56062-847-39 D-0909-2023
Class II · Moderate risk Terminated

Fexofenadine Hydrochloride Tablets

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 0113-0847-39 D-0908-2023
Class II · Moderate risk Terminated

Fexofenadine Hydrochloride Tablets

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 45802-847-78 D-0907-2023
Class II · Moderate risk Terminated

allergy relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 79481-0847-0 D-0906-2023
Class II · Moderate risk Terminated

Allergy ALLER-FEX

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 63981-847-48 D-0905-2023
Class II · Moderate risk Terminated

aller-ease

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 55301-847-39 D-0904-2023
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 69842-0914-39 D-0903-2023
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72476-847-22 D-0902-2023
Class II · Moderate risk Terminated

Non-Drowsy Allergy Relief

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 68391-847-47 D-0901-2023
Class II · Moderate risk Terminated

Allergy

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72288-847-39 D-0900-2023
Class II · Moderate risk Terminated

Maximum Zone2 Topical Analgesic

Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

HTO Nevada, Inc. D-0271-2023
Class II · Moderate risk Terminated

New & Improved Blue Gel Anesthetic

Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

HTO Nevada, Inc. D-0270-2023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 5 mg* 100-count bottle

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-238-01 D-0431-2023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 4 mg* 100-count bottle

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-237-01 D-0430-2023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 3 mg*

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-236-01 D-0429-2023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 2 mg*

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-235-01 D-0428-2023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 1 mg*

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-234-01 D-0427-2023
Class II · Moderate risk Terminated

rOPINIRole Tablets USP 0.5 mg*

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-233-01 D-0426-2023